Senior Analyst, Quality Control Environmental Monitoring, Cell Therapy at AstraZeneca in Gaithersburg, Maryland

Posted in Other about 10 hours ago.





Job Description:

Introduction to role:



Are you passionate about quality control and environmental monitoring? Do you have a strong background in GMP and good documentation practices? If so, we have an exciting opportunity for you! As a QC Environmental Monitoring Analyst, you will be responsible for executing microbial environmental monitoring and testing in our Operations department. This role offers the chance to work on diversified tasks with a global team and be part of multiple projects, while partnering with knowledgeable colleagues across multiple business functions.



Accountabilities:



In this role, you will be expected to demonstrate expertise with methods and techniques for analysis of cell therapy cleanrooms for environmental monitoring. You will be responsible for routine QC lab tasks such as maintenance of equipment and the laboratory as assigned, writing or revising SOPs, and tending or reports. You will also be expected to apply critical thought to solving problems, train new analysts, troubleshoot environmental monitoring equipment, and work closely with management to ensure scheduling.



Essential Skills/Experience:


- Requires a Bachelor's in Biological Sciences, biology, microbiology, or related discipline.


- Or 5+ years of experience in a pharmaceutical or biotech QC environment, with a focus on microbial testing.


- Prior experience in a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell based products, particularly CAR T-cells.


- Ability to work collaboratively as part of a high performing team.


- Excellent interpersonal, verbal and written communication skills in a cross functional matrix environment.


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


At AstraZeneca, we take Quality seriously. Our work is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. We are strong communicators and networkers. With constant exposure to different tasks we're at our best when we're working together as a team. We follow evidence to reach outcomes that benefit patients and AstraZeneca. We adapt to get new medicines out quicker. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk.


Are you ready to make a difference? Apply today and join our team!


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.


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